On January 30 and February 5 ad 6 1997, Mr. Lloyd D. Payne, an
investigator with the Dallas District of the Food and Drug
Administration (FDA), inspected the institutional review board (IRB)
at International Bio-Oxidative Medicine Foundation, Inc. (IBOMF). The
purpose of this inspection was to determine whether your procedures
for the protection of human subjects complied with Title 21 of the
Code of Federal Regulations (CFR) Parts 60 and 56 (enclosure #1).
These regulations apply to clinical studies of products regulated by
FDA.

At the completion of the inspection, Mr. Payne gave a Form FDA 483
(enclosure #2) to Robert L. Santelli, DC, IRB Chairman, describing
the deficiencies identified during this inspection. The deficiencies
listed on this Form FDA 483 repeat the deficiencies listed on the
Form FDA 483 issued after the previous November 28 and December 5, 12
and 19, 1995 Inspection (enclosure #3), Dr. Santelli stated that
neither he nor IBOMF had made any attempt to correct the items on the
Form FDA 483 from the 1995 inspection.

The Agency has reviewed the documents and records relating to the
IRB's responsibilities for the protection of human subjects of
research contained in Mr. Payne's inspection report and the
objectionable conditions and practices listed in the current Form FDA
483. The evidence shows that the IRB has failed to adhere to
pertinent federal regulations as contained in 21 CFR 50 and 56. The
Agency's findings represent significant violations of the Federal
Food, Drug, and Cosmetic Act.

Summary of IRB Membership Violations [21 CFR
56.107]

The IRB has failed to maintain a membership of at least five
members to perform complete and adequate review of research
activities. During the inspection, Dr. Santelli stated to Mr. Payne
that the IRB has no members other than himself. Attempts to contact
the IRB members since September 1995 have been unsuccessful. This
information was also verified by Mrs. Skoshi Farr, Administrative
Assistant.

The IRB's written procedures lacked procedures to ensure that
changes in approved research may not be initiated without IRB review
and approval except where necessary to eliminate apparent immediate
hazards to the human subjects. This is listed on the Form FDA 483 as
item 6B.

The IRB's written procedures lack procedures to ensure prompt
reporting to the IRB, appropriate institutional officials, and the
FDA of (1) any unanticipated problems involving risks to human
subjects or others; (2) any instance of serious or continuing
noncompliance with these regulations or the requirements or
determinations of the IRB; or (3) any suspension of termination of
IRB approval. This is listed on the Form FDA 483 as items 6C, D, and
E.

The IRB failed to review all proposed research at convened
meetings. Two studies were approved by individual votes by telephone.
A third study had an approval letter issued by the IRB, but there is
no record of a convened meeting at which the study was approved. This
is listed on the Form FDA 483 as item 7.

Summary of Continuing Review Violations [21 CFR
56.109(e)]

The IRB has failed to conduct continuing review at intervals
appropriate to the degree of risk, but not less than once per year.
There is no documentation of continuing review of studies at convened
meetings in the minutes of the meetings or elsewhere in the IRB's
files. This is listed on the Form FDA 483 as item #1,

Summary of Record Violation [21 CFR 56.115(a)(1), (3)
and (5)]

The IRB files either lack copies of protocols, investigator
brochure, and informed consent documents or contain incomplete study
information for studies reviewed and approved by the IRB. This is
listed on the Form FDA 483 as items 3, 4, and 8.

The IRB lacks documentation that approved research received
continuing review at least annually. The one except!on was a study
which received continuing review at the July 12, 1991 meeting. This
is listed on the Form FDA 483 as item 1.

The IRB's membership routers lack sufficient information to
describe each member's chief anticipated contributions to IRB
deliberations or to determine the relationship between each member
and the institution. This is listed on the Form FDA 483 as item
#9.

The informed consent for the [redacted] study lacked a statement
that the study involved research and a description of any reasonably
foreseeable risks or discomforts. This is listed on the Form FDA 483
as item 5A.

The informed consent documents for the following studies lack
disclosure of appropriate alternative procedures or courses of
treatment, if any, that might be advantageous to the subject:

[redacted]

[redacted]

[redacted]

The above cited violation may not be all inclusive of the
deficiencies in your IRB
operation.

We note that in the middle of the current inspection, new IRB members were
recruited and a meeting was held on February 4, 1997. Dr. SanteIll announced at
the meeting that all studies, with the exception of the [redacted] were terminated due to
lack of progress reports. Progress reports for the [redacted] submitted by [redacted].

It is not documented in the February 4, 1997 minutes of meeting
that any information (including the names of the studies and the
clinical investigators) for previously approved studies was supplied
to the IRB members for review or that the IRB members were informed
of the letters issued to clinical January 31, 1997 (discussed below).
The next IRB meeting is October 1, 1997.

Your January 31, 1997 letters to clinical investigators request
information on any active studies that the investigators may be
participating in and state that the "I.R.B. will be closing all
investigation studies by March 1, 1997 unless the I.R.B. committee
receives in writing information that would suggest you would like to
continue with your study."

We believe that the February 4, 1997 IRB meeting was ineffective
to ensure that the rights and welfare of research subjects are being
adequately protected. As indicated by the January 31, 1997 letters,
the IRB does not have accurate records of currently active studies
and cannot, therefore, perform continuing review or terminate any
studies. The scheduling of the next IRB meeting for October 1, 1997
indicates that the IRB does not plan to hold a timely convened
meeting to review information received as a result of the January 31,
1997 letters.

We have no assurance that your IRB activities and responsibilities
for insuring that the care of research subjects are in compliance
with FDA regulations. We are concerned that your lack of written
procedures will not adequately protect the rights and welfare of
human subjects of research. Therefore, in accordance with 21 CFR
56.120(a)(l) and (2), we are invoking the following sanctions against
your IRB:

You are to withhold approval of all new studies, subject to the
requirements of 21 CFR Parts 50 and 56, that are conducted at your IRB's
institution, or other clinical studies that are under review and pending
approval by IBOMF; and

You are further directed not to allow any new subjects to enter in or be
added to opened studies that are subject to 21 CFR Parts 50 and 56.

If procedures have been implemented, we request that you submit a
copy of these written procedures to us as pan of your response to
this letter. If appropriate written procedures have not yet been put
in place, or are not put into place immediately, we may take further
administrative sanctions as authorized by 21 CFR 56.120 and 56.121.
These sanctions may include, but are not limited to, the termination
of all previous studies approved by your IRB and disqualification of
your IRB.

Please inform this office, in writing, within fifteen (15) working
days from the date of receipt of this letter, of the corrective
actions you have taken or plan to take to bring your IRB into
compliance with FDA's regulations. You should also include the
following:

any actions taken to turn over responsibility of any future IRB review to
another IRB until such a time as the IBOMF IRB has demonstrated that the
IBOMF IRB can meet the requirements of 21 CFR 50 and 56;

a list of all studies and clinical investigators, including the number of
subjects active at each site;

copies of any letters or other documentation of actions taken.

If you have any questions, please contact Mr. Anthony E. Rodgers
at (301) 594-1026 or Fax (301) 594-1204. Your response shouid be
addressed to the following: